Motor devices for motor nerve root stimulation

ABSTRACT

A motor device for stimulating muscle, including at least one electrode for generating electric current operatively attached to an electrode array and exposed on an inner surface of an array body, and a programming mechanism of a computer that executes an algorithm stored on non-transitory computer readable medium and includes an information storage mechanism and a user-operated interface in electrical connection with said at least one electrode for programming operation of said at least one electrode, said motor device being implanted in an individual and applying electric current to nerves at an area above an area of neurological damage.

BACKGROUND OF THE INVENTION 1. Technical Field

The present invention relates to electrical stimulation of nerves. Inparticular, the present invention relates to electrical stimulation ofnerves to move muscles and regain function of the body afterneurological damage.

2. Background Art

Circumstances arising from trauma, such as motor vehicle accidents,falls, etc., can result in neurological damage involving the spinal cordsuch that the individual becomes paralyzed or loses feeling in one ormany parts of the body. In addition, there are a variety of diseasesthat involve the spinal cord, and can cause progressive loss of muscularcontrol, severely reducing the normal function and quality of life ofthe individual. Likewise, there are a variety of conditions that cancause an individual to feel pain, whether chronically or episodically,in various parts of the body. These and other causes and conditionspresent significant challenges to individuals and their families whostrive to help the afflicted person cope with such disabilities.

The spinal cord extends from the base of the brain to about the waist,extending to the space between the first and second lumbar vertebrae,and is protected by bony processes in the vertebral column. The eightvertebrae in the neck are called cervical vertebrae, and the one at thetop is labeled C-1. Following the cervical vertebrae are the twelvethoracic, five lumbar, and five sacral vertebrae.

The spinal cord nerves, known as the upper motor neurons, function tocarry electrical impulses to and from the brain to spinal nerves alongthe spinal tract. Lower motor neurons are the spinal nerves that branchout from the spinal cord and communicate with specific regions in thebody, initiating actions such as muscle movement. The lower motorneurons emanate from specific vertebrae such that injury to the spinalcord at a particular vertebra causes specific dysfunction in theafflicted person. In general, injuries higher up in the vertebral columnwill cause higher levels of dysfunction. The central problem withneurological damage in the spinal column is the loss of communicationalong nerves at various levels of the spinal column.

There are several methods that are currently used to treat spinal columndamage. Surgery, a variety of drugs, and physical therapy are currentlyused. Experimental treatments include use of stem cell, autologoustransplants, and genetically engineered biological agents.

For example, methylprednisolone is often given within eight hours ofinjury, and while not a cure, it has shown to provide mild improvementthrough reducing damage to nerve cells and decreasing inflammation;however, this treatment has fallen out of favor due to complications.Surgery can be used to repair disks or vertebrae that are compressingthe spine. Physical therapy is used to help persons relearn how to movemuscles or strengthen other muscles needed to perform tasks that werepreviously done with other muscles.

None of these treatments has a high success rate with paraplegics.Surgery has attendant risks, and frequently results in fibrosis at thesurgical site. The use of drugs may not effectively target specifictissues, because drugs must pass through general circulation to get tothe afflicted site, and there may be many adverse effects, such as liverdamage and other unintended consequences of treatment. Physical therapyseems to provide mostly palliative results, due to increased blood flowin exercising of limbs, and cannot provide neurological stimulation atspecific sites when it is needed. Experimental treatments may only beavailable in clinical studies, only in specified institutions orlocations, and so on, and they often have not been fully tested forsafety and efficacy. Complete spinal disruption, anatomical orphysiological, has no current treatment for the complete return offunction.

Spinal cord stimulators have been used to reduce chronic pain byimplantation of wires near the spinal cord. The reduction rate can be50% or greater. Chronic pain is reduced by interrupting nerve conductionof the pain with low level electrical stimulation produced by a spinalcord stimulator. In essence, the spinal cord stimulator produces anelectrical current that competes for the brain's attention with thepain, such that the brain focuses on the electrical current and not thepain.

U.S. Pat. No. 7,610,096 to McDonald, III, discloses methods for thetreatment of CNS damage, and includes inducing in a subject in need ofsuch treatment, a therapeutically effective amount of functionalelectrical stimulation (FES) sufficient to evoke patterned movement inthe subject's muscles, the control of which has been affected by the CNSdamage. The induction of FES-evoked patterned movement at leastpartially restores lost motor and sensory function, and stimulatesregeneration of neural progenitor cells in the subject person. Thetreatment is thought to work by inducing FES-evoked patterned bodymovements that regenerate neural cells such that CNS damage previouslythought beyond repair is repaired, and function previously thoughtpermanently lost is at least partially restored. Without being bound toa particular theory, the FES-evoked patterned movements are thought tostimulate neural regeneration by stimulating neural activity in acentral pattern generator. Physiologic and metabolic demands placed oncells comprising the spinal circuit may activate cellular processes thatpromote new neural cell birth and survival. FES can thereby harness theinnate plasticity of the nervous system. While recovery of function ispossible to the extent that neurons can be created, this particularmethod does not provide a way to recover function when the repair orregeneration needed is too great or not possible.

U.S. Patent No. 7,778,704 to Rezai discloses a method of affectingphysiological disorders by stimulating a specific location along thesympathetic nerve chain. A method is disclosed of affecting a variety ofphysiological disorders or pathological conditions by placing anelectrode adjacent to or in communication with at least one ganglionalong the sympathetic nerve chain and stimulating the at least oneganglion until the physiological disorder or pathological condition hasbeen affected. Physiological disorders that may be treated include, butare not limited to, hyperhydrosis, complex regional pain syndrome andother pain syndromes such as headaches, cluster headaches, abnormalcardiac sympathetic output, cardiac contractility, excessive blushingcondition, hypertension, renal disease, heart failure, angina,hypertension, and intestinal motility disorders, dry eye or mouthdisorders, sexual dysfunction, asthma, liver disorders, pancreasdisorders, and heart disorders, pulmonary disorders, gastrointestinaldisorders, and biliary disorders.

Harkema, et al. (The Lancet, May 20, 2011) describe a method of nervestimulation by implanting an epidural spinal cord stimulation unit. Uponstimulation, patients were able to stand with balance assistance andeventually voluntarily achieve toe extension, ankle deflection, and legflexion. The method of Harkema employs an electrode body having slightcurvature, which is placed on the dura. The shape and the placement ofthe electrode body thereby allow a relatively coarse degree of focusingof the electrical current. The device and method of Harkema does notallow for fine control over the location, intensity, phase, and othercharacteristics of the electrical fields that are applied to the nerveroot. In addition, the selected patients did in fact not have completeinjuries in that the sensory part of the cord remained functional. Thisimplies that partial retention of function must have existed and wasexploited to help return function.

Thus, there remains a need for finer control of electrical stimulation.

While these methods have been developed that electrically stimulate thecentral nervous system or spinal cord, full recovery of movement has notyet been possible. Furthermore, damage to muscles can actually occurwith FES when a muscle is contracted by electrical stimulation butopposing muscles are not relaxed as during normal function of a limb,resulting in tears, blisters, or burns. Other problems persons haveexperienced include dizziness, and autonomic dysreflexia, which is anover-activity of the autonomic nervous system causing an abrupt onset ofexcessively high blood pressure. Persons can experience discomfortduring treatment, such as “pins and needles” under their skin, and atingling sensation caused by the flow of electrical currents passingthrough their body. These sensations can be overcome, but the devicemust be tuned to the user's comfort level (i.e., current type,modulation, waveform, pulse duration and repetition rate, and intensity)or treatment can be unsuccessful. On occasion, the FES electrode'sadhesive or gel can cause users to develop skin irritation and rashes.FES treatment is also not recommended for several person groups whoseconditions would be sensitive to electrodes.

The spinal cord itself carries central nervous motor information elementwithin larger bundles of flowing neurons. Precise targeting isdifficult. Distal nerves are too numerous and difficult to access forsimulation purposes as well, although selective stimulation may extendfunction in conjunction with the current device. Nerve roots on theother hand are well organized into discrete bundles that are moreconducive to exploit for functional purposes, and provide very easyaccess. To date, no formal attempt to stimulate the motor nerve roots,as opposed to the spinal cord or a distal peripheral nerve, in completeparaplegic or quadriplegic patients has caused return of function andmuscle bulk achieving functional results. Stimulation of motor nerveroots has not been exploited to achieve full functional movements.

Therefore, there remains a need for a treatment that addressesneurological damage to the spinal column without adverse affects andthat allows a person to regain mobility and a sense of independence,and/or reduce or eliminate various sources of pain.

SUMMARY OF THE INVENTION

The present invention provides for a motor device for stimulating muscleincluding at least one electrode for generating electric currentoperatively attached to an electrode array and exposed on an innersurface of an array body, and a programming mechanism of a computer thatexecutes an algorithm stored on non-transitory computer readable mediumand includes an information storage mechanism and a user-operatedinterface in electrical connection with the at least one electrode forprogramming operation of the at least one electrode, the motor devicebeing implanted in an individual and applying electric current to nervesat an area above an area of neurological damage.

DESCRIPTION OF THE DRAWINGS

Other advantages of the present invention are readily appreciated as thesame becomes better understood by reference to the following detaileddescription when considered in connection with the accompanying drawingswherein:

FIG. 1 is a top view of the motor device;

FIG. 2 is a view of the motor device in communication with the sensorydevice;

FIG. 3 is a view of the motor device in communication with the sensorydevice and the information harvesting device;

FIG. 4 is a view of the motor device that shows one of the availablepatterns of wire leads and electrode contacts;

FIG. 5 is a view if the interior of the motor device, showing multipleelectrode contacts;

FIG. 6 is a photograph of an electrode at the nerve root;

FIG. 7 is a photograph of an electrode at the nerve root;

FIG. 8A is a side perspective view of the motor device, FIG. 8B is aside perspective view of the motor device, FIG. 8C is a view of an outersurface of flattened array body with leads,

FIG. 8D is a view of an inner surface of flattened array body, and FIG.8E is a cross-sectional view of the motor device; and

FIG. 9 is a photograph of placement of the motor device in a patient.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides methods of stimulating muscle throughelectric current that is especially useful in treating paraplegics,hemiplegics, and quadraplegics, as well as other kinds of neurologicaldamage. The present invention also provides a motor device, showngenerally at 10 in FIG. 1, for bypassing or bridging an area ofneurological damage and providing muscle stimulation that is used toperform the above method, including at least one electrode 12 having amechanism 14 for generating electric current, and a programmingmechanism 16 for programming the at least one electrode 12. The methodand device 10 of the present invention are used to allow an individualwith neurological damage to regain use of their muscles and limbs thathave been rendered non-functional due to their neurological damage, aswell as generally stimulating muscle in a variety of uses.

The terms “bypass” or “bypassing” as used herein, refer to circumventionof diseased areas of the body, preferably non-functioning neuralcircuits. Alternatively, this concept can also be referred to as a“bridge” or “bridging” non-functioning neural circuits in the body inorder to access functioning neural circuits. These terms can be usedinterchangeably herein without departing from the spirit of theinvention.

The term “neurological damage” refers to any damage relating to nervesor the nervous system. “Neurological damage” can include specificallyneural damage wherein neurons are no longer able to communicate and sendsignals to other neurons in a neural circuit.

Most generally, the present invention provides for a motor device 10 forstimulation of muscle including at least one electrode 12 for generatingelectric current operatively attached to an electrode array 18 andexposed on an inner surface 34 of an array body 19, and a programmingmechanism 16 of a computer 28 that executes an algorithm stored onnon-transitory computer readable medium and includes an informationstorage mechanism 30 and a user-operated interface 32 in electricalconnection with the at least one electrode 12 for programming operationof the at least one electrode 12, the motor device 10 being implanted inan individual and applying electric current to nerves at an area abovean area of neurological damage

As shown in FIGS. 2 and 3, the motor device 10 can be in the form of aspecially designed electrode array 18 that can be deployed and wrappedaround a nerve 20 (preferably the nerve root). The electrode array 18can be considered as a cuff 22 that hugs the nerve root 20 or a leadthat lies or is placed parallel to the nerve root 20 or that can lie orbe placed in the epidural space that make contacts 46 with the arearequiring electrical stimulation, as shown in FIG. 4. The electrodearray 18 can also be positioned in or around any other suitable placefor nerve stimulation.

The electrode array 18 can contain operatively attached thereto multipleelectrodes 12 for independent programming of electrical output along anarray body 19, shown for example in FIG. 5, and FIGS. 8A-8E. Theelectrodes 12 appear as a multiplicity of dots or discs exposed on oneside (the inner surface 34) of the array body 19, and they are thecontact areas that conduct electrical impulses to the surface of thenerve root. The amount of electrodes 12 used can vary, however, and asmany electrodes 12 as possible can be used in the available space in theelectrode array 18 in order to stimulate the nerve root 20. Theelectrodes 12 can be aligned about the radius of the array body 19, asin FIG. 8A, or alternating about the radius, as in FIG. 8B.

The side of the array body 19 wherein the contacts are exposed areplaced in proximity to the nerve root and can be referred to as itsproximal or inner surface 34. Each dot or disc contact of the electrode12 includes a wire lead 24 that passes through the array body 19 fromthe inner surface 34 and exits at the distal or outer surface 36 of thearray body 19. The leads 24 have a contacting face (not shown) that isflush with or very slightly inset from the inner surface 34 of theelectrode array 18. After exiting the array body 19, the leads 24 arecovered with an insulating polymer, such that the leads 24 cannotdirectly contact one another. The insulating polymer materials can bethe same or different than the materials of the array body 19 describedbelow. Appropriate insulating material for the leads 24 can include, butare not limited to, silicones (including polydimethylsiloxane (PDMS, DowCorning Sylgard 184)), photo-patternable silicone (Dow Corning WL5150),hydroxylated urethane, polyimides, TEFLON® (polytetrafluoroethylene,DuPont), or other flexible polymers having a high dielectric constant.All materials of the leads 24 are medical grade and/or FDA approved forimplantation. The leads 24 are of a sufficient length to permit theirconnection to a source of electrical current.

The array body 19 can have a long axis L from 2 to 3 cm, shown in FIG.8B. When mounted on a nerve root, this axis will be oriented along thelength of the nerve. The array body 19 also can have a short axis S from2.2 to 2.8 cm. This short axis can be wrapped around the nerve root,whose natural diameter is approximately 4-5 mm.

The disc or dot contacts of electrodes 12, along with their leads 24,can be composed of any variety of materials that include, but are notlimited to, surgical stainless steel, gold wire, an indium/gold alloy,photo-patterned gold, layers of photo-patterned chromium and gold, oranother conductor that is selected for the properties of low impedance,chemical stability and low bioreactivity, as suitable for a chronicallyimplanted medical device. The conductor material must be suitable andstable enough to allow for chronic implantation for periods of months toyears. The contacts of the electrodes 12 are arranged along the innerface 34 of the array body 19 in circumferential rows that run across theshort axis of the array body 19, with leads 24 running toward the outersurface 36. The appearance of the array 18 on the inner proximal face 34of the array body 19 is of lines of dots, 0.1 to 2.5 mm diameter,extending across the short face of the array body 19. The distancebetween lines may be varied, from 1 mm to 1 cm, depending on thespecific performance requirements of the intact array 18.

The array body 19 can be formed as a flat sheet and composed of abiologically non-reactive polymer that is pliable and is able to easilywrap around the nerve root 20 to conform to its shape, such as, but notlimited to, silicones (including polydimethylsiloxane (PDMS, Dow CorningSylgard 184)), photo-patternable silicone (Dow Corning WL5150),hydroxylated urethane, polyimides such as Pyralin 2611, TEFLON®(DuPont), polyrurethane, polydimethylsiloxane or other silicones, orother polymers. The array body 19 materials should have the followingproperties: it is an electrical inert polymer, the polymer is chemicallyinert and has low bio-reactivity, the polymer is FDA approved forimplantation, and the polymer is very soft with a low Young's modulus tominimize nerve damage.

The diameter of the electrode array 18 can vary depending on the size ofthe nerve root that it is surrounding. TABLES 1-4 provides examples ofdiameters of nerve roots and electrodes. TABLE 4 shows the relationshipbetween contact diameter and number of contacts based on gross electrodedimensions.

TABLE 1 from Guvencer 2007. J Clin Neurosci 15:192-7. Width, mm levelmean dia, mm sd mean sd L1 4.9 0.5 15.4 1.6 L2 5.5 0.6 17.3 1.9 L3 6.50.7 20.4 2.2 L4 7.2 0.9 22.6 2.8 L5 7.5 1 23.6 3.1

TABLE 2 from Ebraheim 1997, Clin Orthoped 340, 230-5 Width range Widthlevel range, mm ave, mm sd max= min= ave L1 4-6 4.9 0.7 12.6 18.8 15.4L2 4-7 5.5 0.9 12.6 22.0 17.3 L3 5-8 6.3 1 15.7 25.1 19.8 L4 6-8 7.0 0.918.8 25.1 22.0 L5 5-8 7.0 0.9 15.7 25.1 22.0

TABLE 3 Diameter est from Hogan (1996) areas Hogan's fold Ebraheim levelarea difference diameter T12 0.7 1 L1 0.73 1.042857143 4.9 L2 1.31.857142857 5.5 L3 2.4 3.428571429 6.3 L4 1.87 2.671428571 7 L5 2.31 3.3S1 2.62 3.742857143 S2 1.18 1.685714286

TABLE 4 Width Nerve root (circum.) of (1) electrode Center-to-centercontact distance in mm Width range Diameter, body, mm per number ofcircumferential contacts max= min= mm =3.1416 × dia 4 6 8 12 16 110% 90%4 12.6 3.14 2.09 1.57 1.05 0.79 13.8 11.3 4.5 14.1 3.53 2.36 1.77 1.180.88 15.6 12.7 5 15.7 3.93 2.62 1.96 1.31 0.98 17.3 14.1 5.5 17.3 4.322.88 2.16 1.44 1.08 19.0 15.6 6 18.8 4.71 3.14 2.36 1.57 1.18 20.7 17.06.5 20.4 5.11 3.40 2.55 1.70 1.28 22.5 18.4 7 22.0 5.50 3.67 2.75 1.831.37 24.2 19.8 7.5 23.6 5.89 3.93 2.95 1.96 1.47 25.9 21.2 8 25.1 6.284.19 3.14 2.09 1.57 27.6 22.6 8.5 26.7 6.68 4.45 3.34 2.23 1.67 29.424.0

The electrode array 18 can be secured into place by tissue glue,sutures, stay screws, or alternatively, the stiffness of the device 10with specially designed silicon holders with imbedded electrodes 12.Electrode array 18 can be produced with multiple flaps or flange 38along the long axis. For example, four flaps 38 are shown in FIGS. 8Cand 8D. These flaps 38 can be supplied with small holes 44, toaccommodate suturing by the surgeon. The flaps 38 can be arranged inopposition or can alternate, thereby allowing options for the surgeon.The suturing is performed such that the body 19 of the electrode array18 makes direct contact with the nerve root, but also such that it doesnot impose compression upon the nerve root. With time, scar tissue helpsprevent migration of the electrode array 18. By securing the electrodearray 18 in a position symmetrical around the nerve root 20, the appliedelectrical current can be exploited at any particular electrode 12, orcombination of electrodes 12, thereby stimulating a more diversecross-section of nerve roots 20. The electrodes 12 can play off oneanother in terms of the cathodes and the anodes, as required to avoidtissue damage, and can apply steering current using tripodal electrodesor other arrangements of electrodes, but this allows maximal control inthe stimulation of the nerve roots 20 and particularly of nervefascicles within nerve roots. The principle of motor nerve activationcan also be extended to the use of multiple electrode arrays 18, placedon nerves or nerve roots 20 selected for their ability to stimulatemuscular contraction. Such multiple electrode arrays may be stimulatedin a coordinated fashion, as required, to obtain the desiredcapabilities that result from muscular contraction, such as locomotionand resolution of foot drop and of arm paresis.

The electrodes 12/electrode array 18 can be constructed in whole or inpart by 3D printing technology. Such 3D printing technology preferablyhas two components 1) a mapping step, using fiber optic cameras to guidethe surgeon and to measure nerve dimensions; and 2) a constructing step,using a 3D printer that is fitted with printer heads or other mechanismsto deposit or print in 3D space using technology concepts of additivemanufacturing.

For example, for the mapping step in the case of motor nerve roots, oncethe surgeon has accessed the motor nerve roots, endoscopes can be usedto chart the contours and various dimensions of the nerve root surface.Small incisions can provide access of the endoscopes. Data collected viaoptical fibers or other methods of transmission can be decoded bysoftware to the actual dimentions of the nerve roots, as well as otherlocal features of significance.

The constructing step can be accomplished in two different ways with aconstructing device including 3D printing. First, the constructing stepcan be extracorporeal, or outside the body. Second, the constructingstep can be intracorporeal, or within the body. Both technologies useprinciples and means employed in additive manufacturing, or 3D printing.Thus, they both can be0 controlled by software that can translate themapping data from the initial mapping step, thereby controlling thedeposition of material.

The extracorporeal construction can produce electrodes 12 within thesurgical field, using principles of 3D printing, and whose electrodes 12can subsequently be placed around or adjacent to the nerves of interest.Alternatively, electrodes 12 can be produced at remote locations andsurgically implanted at a later time.

The intracorporeal construction can utilize the same principles, withthe exception that the printing events occur within the body. Toaccomplish the latter, print heads can be controlled by means of theendoscopes that are used to map the nerve surface. In an ultimate formof the intracorporeal device, mapping and printing devices can be joinedinto a single device whose functions are coordinated such that electrodeconstruction can be accomplished immediately after mapping of the nervesurface.

Both methods of construction can construct nerve electrodes 12 having atleast two distinctly different electrical properties, i.e, those of theinsulator and of the conductor. The substrate that provides suchproperties is different materially and chemically; thus, theconstructive device includes at least two different print heads or othermeans of deposition. One such print head can supply the insulatingmaterial that forms the electrode 12 body. Such material can be a softelastomeric plastic or other nonconducting polymer that conforms to theouter surface of the nerve. This insulating material provides a soft,compliant surface, so to conform to the shape of the nerve root or nerveof interest. Such material can have the desired conformation andflexibility upon construction, or can be photo-curable, utilizing anoptical fiber directing ultraviolet light. The other print head cansupply the electrically conducting material. Such material, which comesto direct or very close contact with the nerve root, can also be aflexible and compliant material. Examples of such materials are alloysof indium and gallium, whose admixture can be used to produce electricalconductors that are soft, conforming and stretchable. Suchindium/gallium alloys are liquid at room temperature, yet form a “skin”upon contact with air or other weak oxidant. Thus, such a printer can befitted with print heads that provide the conductor, and that provide aweak oxidant in sterile saline.

Therefore, the present invention provides for a method of preparingelectrodes, by mapping nerve dimensions and features, and constructingelectrodes with a 3D printer either extracorporeally orintracorporeally.

The electrode array 18 can further include at least one generator orbattery 26 that provides electrical current to leads 24 that causeselectrical transmission through nerves distal to the point of contact.Preferably, the battery 26 has a long life so that it does not need tobe replaced often or require additional surgery. Preferably, the battery26 includes enough inputs to connect with and to handle various energyoutput requirements by all of the components of the device 10.

As mentioned above, the electrode array 18 can be programmable and thusincludes a programming mechanism 16 such as a computer 28 to execute analgorithm or software stored on non-transitory computer readable mediumand a storage mechanism 30 to store the algorithm or software and anydata collected or produced by the algorithm or software, such as RAM,ROM, flash storage, cloud-based storage, or any other storagemechanisms. Preferably, the computer 28 includes a user-operatedinterface 32 that can be programmed or operated by a user, such as adoctor or the person. The computer 28 via the algorithm directly sendssignals to the device 10 to cause fluid and natural motion, such asmoving a limb or walking. The computer 28 can also communicatewirelessly with a remote interface 32 (shown in FIG. 1), such as, butnot limited to, a smart phone, or a touch screen device, avoice-activated device, or a thought-activated device operated directlyby the person's own brain signals.

The algorithm can include instructions such as, but not limited to, howoften to apply electric current, which nerve to apply current to, andhow strong is the applied current. Additional parameters can beprogrammed and set and can include any combination of the following: thetiming of electrical potential applied at different electrodes 12 in theelectrode array 18 and/or in multiple electrode arrays used on amultiplicity of nerves and/or nerve roots 20; varying the intensity ofelectrical current applied at different electrodes 12 in the electrodearray 18; the use of variable frequency trains; relaxation kinetics;stimulation frequency; shortening history; and random modulation ofparameters, including: constant stimulation, randomized frequency,randomized current amplitude, and randomized pulse width. The battery26, leads 24, electrodes 12, and program parameters are all adjusted tominimize pain felt by the person.

Most generally, a method of stimulating muscle in a person havingneurological damage is provided by applying electric current to nerves,bypassing or bridging an area of neurological damage, and moving themuscle in a natural manner. Preferably, this method is performed withthe motor device 10 as described above. While the method can be usedwith any type of muscle damage, most preferably, the present inventiontakes advantage of the organization of motor nerves inferior to thespinal level transected by injury or affected by disease. In otherwords, the muscles can be stimulated to move as if the individual hasnot experienced any neurological damage and natural flowing movement(i.e. not jerky movement) of the muscles can be produced.

The electric current can be applied to various nerves, including, butnot limited to, central nerves, nerve roots, or peripheral nerves. Nerveroots carry very specific information to well mapped out myotomes andtherefore this information can be exploited in this mapping to stimulatethe muscle groups required to cause motion. Preferably, electric currentis applied to a nerve bundle in order to stimulate a muscle groupinstead of just a single muscle, in order to provide natural movement.In other words, the stimulation is a coordinated muscle groupstimulation. Electric current can be applied by inserting the motordevice 10 including electrodes 12 into the spinal canal, or selectedperipheral nerves, so that they become in intimate contact with nerveroots therein. Alternatively, the device 10 including electrodes 12 canbe placed in close proximity of specific sensory (afferent) neurons. Asdescribed above, the electrode array 18 of the device 10 can be wrappedaround the nerve root 20 or lie parallel to the nerve root 20. Inaddition, more specifically, the electrode array 18 can be placed alongthe nerve root at the L5-S1 level, parallel to the S1 nerve root.Stimulation of the nerves can generally be within levels T12 through S1.Stimulation can also be to any individual axon within a nerve root. Theuse of a multiplicity of contacts of electrodes 12 within a nerve rootcan allow for selective stimulation of individual axons, stimulation ofcombinations of axons, summation by multiple contacts along individualaxons, variations of frequency and intensity, and other individual andcombined stimulatory events, such that muscular contraction is caused asdesired.

More specifically, the motor device can be inserted by a method such as,but not limited to, translaminar percutaneous insertion, translaminarinsertion via surgical laminotomy, surgical foraminotomy, and surgicalimplantation around and adjacent to a peripheral nerve. In eachinsertion technique, nerves, central nerves, nerve roots, or peripheralnerves can be accessed. The device 10 can be deployed percutaneously orwith direct surgical visualization for any technique. The extraforaminalroute places the device 10 directly over the nerve root. Thetranslaminar route places the device 10 around the nerve roots andparallel to the nerve root. With an intradural route, the dura is openedand the device 10 is placed directly over a nerve root, resulting in avery sensitive placement and robust stimulation. Epidural stimulationadjacent to the nerve root can also stimulate the nerve root to increaseeffectiveness to increase or decrease muscle tone, and epiduralplacement in the thoracic spine or cervical spine area can be used tostimulate the spinal cord and the variety of movements can bespecifically programmed. The use of multiple devices 10 moreover can beused for coordinated stimulation of major muscle groups used for walkingand other activities. The device 10 can be attached to a sensory device40 (i.e. sensory electrodes, described below) to send signals above thespinal cord injured level.

As a result of the electric potential provided by the electrodes 12,nerve signals can cross the neuromuscular synapse and bypass or bridgeareas of neurological damage, thereby causing muscles to contract orrelax as needed. More specifically, in the preferred embodiment of theinvention, the electric current is applied to an area right above anarea of neurological damage, where it bypasses or bridges the area ofneurological damage, and travels to an area below the damage in order tostimulate muscle. This process requires an understanding of where aneurological signal was coming from above the area of neurologicaldamage as well as where that signal needs to travel to, such as directlyin the spinal cord or in a muscle or muscle group itself, in order tocorrectly stimulate muscle. This is an important process in the presentinvention. One of the main reasons that people with neurological damagecannot function as normal and move their limbs is because the musclesrequired for movement cannot receive signals from neurons to stimulatethe muscles. There is generally an area along the synaptic pathway thatis damaged such that a signal generated in the brain to move the musclecannot reach its intended target muscle due to this damage. By creatinga bypass, electric current as applied in the present invention can reachthe intended target muscle, allowing an individual to move that muscleas normal. Thus the present invention can precisely target motor nerveroots, and also peripheral neurons that are responsible for general orspecific areas of the body and that can be injured such that theirfunction is compromised, essentially reversing the effects ofneurological damage.

Not only can the electric current can be applied above an area ofneurological damage and bypass or bridge damaged nerve areas as statedabove, but also below an area of neurological damage directly withoutthe need for a bypass or bridge. Therefore, the present inventionprovides for a method of stimulating muscle in a person havingneurological damage by applying electric current to nerves, therebymoving the muscle in a natural manner. This method is especially usefulwhen a very specific muscle group is desired to be moved or a persononly desires to have their muscle perform a specific function. In thiscase, it is not necessary to bypass or bridge an area of neurologicaldamage. For example, this method can be useful in providing bowel orurinary tract function control in individuals who have lost such controlsuch as by providing sphincter function to contract or relax muscles ortone via S2-S4 stimulation or stimulating nerves related to urinarytract control with detrusor function to cause the urinary tract musclesto contract or relax to control urine flow, or providing sexual functionwhen loss has occurred by stimulating nerves realted to sexual function.This method can also be useful for exercise or stimulation of muscles ofindividuals, in rehabilitation of particular muscles, or in space whereastronauts can suffer from loss of muscle tone due to low gravity. Themethod of stimulation for exercise is further described below.

The methods of the present invention, along with the appropriatecontacting electrodes 12, and computer algorithm(s) of the motor device10, are useful to allow person control, and are intended to allowpersons to move digits, limbs and other body parts that have becomeparalyzed due to trauma and/or disease resulting from a broad spectrumof causes and especially by loss of nerve function. Thus, in thesuccessful use of this invention, a paralyzed individual can becomecapable of standing, flexing muscles, and motility such as walking. Inother words, use of the device 10 of the present invention can allow anotherwise paralyzed person to regain function of their body. Thisinvention can be used as an interventional treatment for persons who areparalyzed due to spinal cord involvement. This invention can be used asan interventional treatment for persons having arm paresis due to acerebrovascular accident or stroke. This invention can also be used totreat persons who, due to spinal cord injury, have lost feeling inspecific parts of the body. Additionally, this invention can be used toreduce or eliminate the feeling of pain felt at peripheral locations bythose individuals who feel chronic pain. The methods and device 10disclosed herein can be used with any individual that has neurologicaldamage.

The present invention provides more specifically for a method of movingmuscles of a paraplegic, by applying electric current to nerves,bypassing or bridging an area of neurological damage, and movingnormally non-functioning muscles, and thereby moving normallynon-functioning limbs. By using the motor device 10 as explained above,this method can allow a paraplegic to regain function of any part of thebody that had been rendered non-functioning by their condition. Forexample, by applying electric current to appropriate nerves, musclesrequired for walking can be stimulated and moved, thereby allowing theindividual to walk by moving their legs.

The present invention further provides for a method of reducing oreliminating pain from an individual, by applying electric current tonerves, bypassing or bridging an area of neurological damage, andreducing or eliminating pain. Preferably, this method is performed byusing the device 10 described above. The electric current acts toinfluence the processing of information within the central nervoussystem, and increase peripheral blood flow. The intrinsic nervous systemof a muscle is interposed between the information processing of thecentral nervous system and muscle function, so the electric current canmodulate the processing of the pain experienced at the muscle. Thedevice 10 can be placed following the nerve root in order to reduce andeliminate pain

The present invention further provides for a method of treating footdrop, by applying electric current to nerves, bypassing or bridging anarea of neurological damage, and regaining feeling and function of adamaged foot. In foot drop, the individual is unable to lift, or findsdifficulty in lifting, the front of the foot when walking. This methodis preferably performed by using the device 10 as described above.

This condition can result from direct injury to the spinal cord, alongwith degenerative conditions such as multiple sclerosis. A recenttreatment for this condition uses the Ness L300 system (Bioness, Inc,Valencia, Calif.). This system provides electrical stimulation toperipheral muscles, specifically the anterior tibialis, in response tothe foot being lifted from the ground. No other nerves involved inwalking are influenced by the Ness L300. The present invention providesa distinct improvement on the Ness L300. In the resulting improvement,the electrical stimulation is directed at the nerve root in the spinalcord, for example, at neurologic level L4, thereby allowing theindividual to both flex the foot and lift the leg while walking, whichmore closely resembles the gait of a healthy individual. Along withallowing greatly improved motility, the use of the present invention canreverse or dramatically diminish the extent muscle atrophy.

The method of the present invention can be used as a combinationtreatment with other therapies that are currently used for treatingneurological damage, or whose use is currently under investigation. Forexample, the present invention provides for a method of stimulatingmuscle in a person having neurological damage by treating the personwith stem cells, applying electric current to nerves, bypassing orbridging an area of neurological damage, and moving the muscle in anatural manner. This method is especially helpful when the currenttherapy can be expected take months or years to take effect, if at all.Stem cell therapy applied to the spinal column may not produce resultsfor five years or more. In the meantime, by combining the stem celltreatment with the present invention, muscle can be stimulated,exercised, and strengthened in anticipation of the treatment beingeffective. Thus, the electrical stimulation can have an adjuvant effectwith stem cell treatment in providing the restoration of naturalfunction. This method is preferably performed by using the device 10 asdescribed above.

The method of the present invention can also be used as a therapeuticmethod for exercising for an individual with neurological damage byapplying electric current to nerves, bypassing an area of neurologicaldamage, and stimulating and exercising muscles that otherwise would notbe stimulated due to the neurological damage. This method allows anindividual's muscles to be exercised through contraction and relaxationand to grow stronger over time due to the stimulation by electriccurrent. This method of exercise is more natural than by exercising withmachines or a physical therapist, as the there is less risk of damage tomuscles due to natural movement through the electrical stimulation.While an individual may not be strong enough at first to use certainmuscles, over time by performing this method, the individual can buildstronger muscles and eventually use the limbs that the muscles control.This method is preferably performed by using the device 10 as describedabove. The method can also include the steps of increasing muscle bulkand strength, independent of function. This can allow for core musclegroups, such as abdominals and paraspnals to be bulked up, helping withstability and preventing deformity.

With all of the methods of the present invention, therapy andrehabilitation with a therapist can be required to train a person tobecome comfortable with the capabilities of the device as well as therestrictions of their own body. Initially, the movements can bedifficult to control, and working with a therapist allows for the rightparameters to be programmed into the device 10 to provide naturalmovement. This also allows the person to get used to the flow of currentand the meaning of the current in terms of movement of the body.

The device 10 and methods of the present invention can also be used incombination with a mobile standing device, such as, but not limited to,the STANDING DANI® (Davis Made, Inc.) as well as other such assistivedevices. Once the device 10 is implanted in the person, the mobilestanding device can be a failsafe where the person can gradually becomefurther and further in control of their own legs as they becomecomfortable with the programming and become stronger. The device 10 canbe used in like fashion in combination with other such assistivedevices, another example of which includes devices for upper limbrehabilitation used to regain arm function following stroke. Thus,device 10 can broadly be applied in cases of paralysis or othermovement-related disorders of the body.

The device 10 of the present invention overcomes the problems ofelectrical stimulation devices of the prior art because multiple musclesor areas of muscles can be stimulated at once, thereby allowing fornatural movement of muscles and elimination of damage of muscles due tocontraction without corresponding relaxation. An indirect positiveoutcome is that causing muscular contraction can stimulate boneregeneration, thereby making bones stronger, or at least reducing therate of bone loss. The use of motor nerve roots is a more elegantsolution than is the use of peripheral transcutaneous stimulation ortransepithelial stimulation (TES): it is applied at the spinal cord atthe level of injury, can eliminate the muscle tears, blisters, rashes,burns, and dizziness found with percutaneous TES. This method canovercome a major disadvantage of poor stimulation selectivity and allowmore natural walking patterns than surface electrodes, thus being moresuited as a prosthetic device for chronic use. The present inventionalso improves on commercially available pulse generators because of themultiplicity of electrodes 12 per nerve root. Nerve root stimulationalso can interact with the central pattern generator of locomotion,which represents organization among spinal neurons. Activating thecentral pattern generator can cause coordinated muscle contraction as inlocomotion, and so can result from stimulation of a small number ofsites on the nerve roots. The present invention provides the capabilityof fine-tuning such stimulation.

The motor device 10 can also be electronically connected to a sensorydevice 40, shown in FIG. 2 (not shown to scale), having a biofeedbackmechanism 42 to send information to the spinal cord and sensory nervesand the brain as a part of a biofeedback loop so that the person can“sense” the movement. Information harvested from the motor stimulationcan be sent to a spot above the level of spinal cord injury to an intactsegment to then help the body “feel” the movement. The information canbe sent by wired communication or wireless communication between themotor device 10 and the sensory device 40. The sensory device 40 canfurther include computer storage and algorithm mechanisms to control andsend information stored on non-transitory computer readable medium. Boththe motor device 10 and the sensory device 40 can be independentlyprogrammable via an external source. Therefore, the present inventionprovides for a biofeedback system including the motor device 10 inelectronic communication with the sensory device 40 having thebiofeedback mechanism 42 to send information generated by the motordevice 10 to the spinal cord. The sensory device 40 can includeelectrodes 12, which can have any of the properties or construction asdescribed above. The sensory device 40 can be any suitable sensor knownin the art that can sense various biological properties of anindividual.

The present invention further provides for a method of generatingmovement of muscle and sensing that movement in a person havingneurological damage, by applying electric current to nerves, bypassingan area of neurological damage, moving the muscle in a natural manner,and sending information of the movement to the spinal cord, therebyallowing the person to sense the movement. Preferably, this method isperformed by using the motor device 10 and sensory device 40 asdescribed above. Each of these steps has been described above, with theapplying, bypassing, and moving steps being performed by the motordevice 10, and the sending (and sensing) step being performed by thesensing device 40. This method allows an individual with neurologicaldamage and inability to move muscles in a normal manner to move thosemuscles as well as sense that movement.

In one example of this method, if a person has a T10 paraplegia, thedevice 10 can be hooked up such that it now bridges the T10 injury atapproximately the T8 or T7 level and as the device 10 is turned on,unique sensory signals can be sent back to the brain via the intactspinal cord at around the T7 level, thereby creating a biofeedback loopand the person is then aware of the motion of their legs through truesensory patterns which are unique for every particular motion.

Also, the biofeedback loop can be completed by linking the motor device10 to an information harvesting device 50 that includes a mechanism 52for harvesting information directly from the brain and motor cortex, asshown in FIG. 3. The information harvesting device 50 can then sendinformation to the motor device 10 to create a complete parallelstructure referred to as an “artificial spinal cord”. Again, theinformation can be sent by wired communication or wireless communicationbetween the information harvesting device 50 and the motor device 10.This allows the person to directly control the movement of muscles thatare stimulated by the motor device 10 instead of relying on a program toactivate the electrical stimulation of the muscles. The informationharvesting device 50 can further include any computer or algorithmmechanisms as necessary to communicate with the motor device 10, storedon non-transitory computer readable medium. Essentially, the informationtransmitted by the information harvesting device 50 is translated by themotor device into electric current needed to apply to the nerves. Theinformation harvesting device 50 can be a sensor known in the art thatis capable of sensing signals from the brain and motor cortex.

Therefore, the present invention provides for an artificial spinal cordincluding the motor device 10 as described above for bypassing an areaof neurological damage in communication with the sensory device 40having the biofeedback mechanism 42 to send information generated by themotor device 10 to the spinal cord, and the motor device 10 being incommunication with the information harvesting device 50 having themechanism 52 to harvest information directly from the brain and motorcortex and send to the motor device 10.

The present invention further provides for a method of generatingmovement of muscle and sensing that movement in a person havingneurological damage, by harvesting information directly from the brainand motor cortex to move muscle, translating the information into theapplication of electric current to nerves, bypassing an area ofneurological damage, moving the muscle in a natural manner, and sendinginformation of the movement to the spinal cord, thereby allowing theperson to sense the movement. Each of these steps is described above andthese are preferably performed by the motor device 10, the sensorydevice 40, and the information harvesting device 50, and by performingthis method, a person having neurological damage can bypass their ownspinal cord and areas of neurological damage. The person can generatethe signal to move their own muscles, allowing them to move in a naturalmanner. This method is especially useful to those people who havesignificant damage to their own spinal cord.

The motor device 10 of the present invention can further be used in adiagnostic method by applying electric current to nerves, measuringmovement of muscle due to the electric current, and based on the amountof muscle movement, diagnosing a person as having neurological damage.This method can be used to determine whether there has been neurologicaldamage to an area of the body, as well as to determine whether a certainamount of electric current can bypass the area of neurological damage tostimulate and move the muscle. If a muscle fails to move or moves lessthan expected, then neurological damage has occurred. This method can beused to determine how effective the electric current is at bypassing thearea of neurological damage and moving the muscle. The steps of thismethod are essentially performed as describe above. The electric currentcan be applied to any nerves in the body in this method.

Any of the above methods can be combined to produce different results inthe body. For example, the method of reducing or eliminating pain can becombined with the method of stimulating muscle in a person havingneurological damage, as shown in Example 3. In other words, the device10 can provide several different positive effects in the body, dependingon the particular needs of the person.

The present invention provides many advantages over the prior art. Thepresent invention utilizes circumferential electrode bodies thatmaintain direct contact around the circumference of the nerve root. Amultiplicity of electrical contacts are placed within the electrode bodyand thereby are placed in immediate proximity to the nerve. Thesemultiple contacts are placed in direct contact with the nerve surface,so to allow a fine degree of control over the location, intensity, phaseand other characteristics of each of the electrical fields that areapplied to the nerve root. This is of particular significance whenstimulating a nerve root, due to the presence of multiple nervefascicles within the nerve root. Thus, the present method allows a veryfine degree of control in stimulating nerves within the nerve roots,which by its design improves on prior art methods described above.Direct circumferential contact of nerves, by the device in the presentinvention, thus has advantages that include a finer and more targetedcurrent applied directly to the surface of the nerve; reduced currentdemands that lower the potential for tissue damage and minimize energyconsumption; and more consistent contact of all electrical contactswithin the electrode body.

The invention is further described in detail by reference to thefollowing experimental examples. These examples are provided for thepurpose of illustration only, and are not intended to be limiting unlessotherwise specified. Thus, the present invention should in no way beconstrued as being limited to the following examples, but rather, beconstrued to encompass any and all variations which become evident as aresult of the teaching provided herein.

EXAMPLE 1

Under the supervision of the onsite veterinarian, and under asepticconditions, rats were anesthetized and kept under conscious sedationwith appropriate analgesics, as per the veterinarian. Local anestheticswere injected and a midline incision was made getting down to thelamina. Laminontomies and laminectomies were performed utilizing a highspeed Midas Rex Drill. The dura and nerve roots were exposed andepidural leads were directly placed over the top of the nerves.Electrodes were subsequently connected to the neuromodulator device,which when activated caused motor contractions in the correspondingmuscles. Quantitative results could not be obtained due to the largesize of the electrodes relative to the very small fine nerves of therat, which caused difficulty in reproducible electrode placement.However, the observation was made in every case that spinal cord nerveroot stimulation caused motor contractions in the corresponding muscles.

EXAMPLE 2

In the course of electrode placement for treatment of pain in aparalyzed person, an eight-contact epidural lead was placed at theforamen covering the nerve roots at neurological levels L5 and S1. Thisprocedure was performed by a neurosurgeon using a cannulated catheterand was guided by fluoroscopy. The act of programming of the spinal cordstimulator caused the person's foot to flex. This result indicates thatmotor nerve root stimulation in the spinal cord can, indeed, causecontraction of corresponding muscles.

EXAMPLE 3

John is a 47 year old male who underwent multiple spine surgeries andended up having chronic back pain as well as left leg pain and weaknessrequiring neuromodulation. Multiple medications were tried andultimately, he required a spinal cord stimulator to be placed in histhoracic level to try to control his pain. This helped him with is backpain but did not fully control his leg pain and the pain that wasdistributed down his L5-S1 nerve root level was persistent despite theneuromodulator taking away part of his pain. In these difficult cases,retrograde leads can be utilized following the nerve root and this cantake away the pain. The patient had an eight electrode linear arrayplaced along the nerve root at the L5-S1 level, parallel to the S1 nerveroot. This produced paresthesia thereby decreasing the patient's pain.It was placed in a manner that it also was capable of causing motorstimulation, therefore this was exploited in a post operative period tocause his leg to move.

The procedure was done through a laminotomy approach with a paramedianincision in the back over approximately the L5-S1 level. A drill holewas placed into the lamina and then got into the epidural space wherethe lead was placed in. The leads were secured to the soft tissue with alead anchor and tunneled in a subcutaneous fashion to a BostonScientific generator.

Once the procedure was done and the device was being held in place,appropriate foot and leg movement was programmed and caused. This wasdone a few days later and thereby proves the concept of foot motionutilizing neuromodulation within the realm of the currents and voltagesgenerated.

The area that was stimulated was mainly the S1 nerve root and one couldsee muscle contractions with his leg movement as a result ofstimulation. As shown in FIGS. 6 and 7, the electrode hugs the nerveroot.

EXAMPLE 4

In this case study multiple electrodes were placed from L2 to S1 alongthe nerve roots of a T5 traumatic paraplegic patient who had not movedher legs for two years. By connecting to battery power and usingcomputer algorithms to modulate individual nerve roots, precise andsynchronous myotome movements were achieved.

Methods

The patient is a 32 year old female left with complete T5 paralysis fortwo years after suffering a T5 burst fracture after falling from a tree.She had cord compression in the cervical spine causing full return ofupper extremity function. T5 posterior fusion and decompression wasperformed to stabilize her but the injury was complete, with no returnof function after two years. A baclofen pump was inserted into the L3level for spasticity months later. She remained a highly motivated,positive patient despite the devastating injury.

After obtaining informed consent from the patient, a total of 8 leadswith 8 electrodes each were implanted at L2, L3, L4, and S1 bilaterally.4 leads for a total of 16 electrodes on each nerve root with two leadseach were implanted at L5 bilaterally.

The procedure was performed under general anaesthetic with a smalllaminotomy at T12 to facilitate retrograde insertion of percutaneousleads to each level. The anatomy of the interlaminar space would notallow for an appropriate trajectory of insertion without a laminotomy. Alaminotomy may be avoided by using extra foraminal approaches to eachnerve root, antegrade placement with significant bends on introducerswires or in patients with large interlaminar space anatomy or directsurgical cut downs to each level. The current approach was taken tominimize surgical time and achieve the highest accuracy of placement.Total surgical time was approximately 120 minutes.

A total of 2 batteries with four ports each were utilized connecting 8electrodes to D port for S1, 16 electrodes with a splitter to C port, 8electrodes from L4, and 8 electrodes to L3 with a splitter to B port and8 electrodes to A port form L2.

They were anchored into the interspinous ligament and tunneled to twoseparate gluteal pockets on either side. All electrodes from the leftwere sent to the left battery and right electrodes to the right battery.This allowed for a total of 64 contact points (32 per battery) on 12leads with implantation of 96 electrodes that covered L2 to S1bilaterally. A larger array of leads and batteries can be used forsimilar patients as resources become more readily available. Each leadhugged the posterolateral gutter of the spinal canal before exitingalong with the nerve root out the respective foramen (see FIG. 9).

After recovery, the patient was sent home the same day and allowing oneweek for healing, the patient was brought to an outpatient setting andprogramming ensued.

Motor movement was evaluated with the following:

0 no movement

1 trace licker

2 very weak cannot lift against gravity

3 can resist gravity

4− weak but stronger then 3

4 moderate strength less then normal

4+ moderate strength less then normal

5 normal strength

Observations are shown in TABLE 5.

TABLE 5 L2 Right knee extension 4+ hip abduction 4− ankle and toeextension 3 Left knee extension 4+ hip abduction 4− ankle and toeextension 3 L3 Right 3 Left 3 L4 Right 3 Left 3 L5 Right 3 Left 3 S1Right 3 Left 3

Function was evaluated of standing, leg bending at knee, leg extensionat knee, leg strengthening currently measuring calf and thighcircumference, and straightening.

Problems reported were goosebumps, no blood pressure or heart ratechanges (could happen if stimulation is perceived as irritating orpainful to the nerve root, different parts of the nerve root anddifferent configuration produce different results, and possible nerveroot or muscle damage by prolonged stimulation and fatigue or too high avoltage or intensity.

Conclusion

This case report demonstrates the ability to modulate motor nerve rootsin precise, replicable and targeted manners. This will certainly help inincreasing muscle mass, and has proven function can also be achieved.This indicates that the next era for motor neuromodulation of the nerveroots brings promise to reanimation of paralyzed limbs. The currentpatient has shown a variety of increasing abilities to weight bare andmove her legs in a controlled fashion with improvement being achieved ona weekly basis. A cuff lead with circumferential electrodes with thesmallest possible contact points will allow greater variety of electronclouds to be delivered leading to more diverse functional effects.

Throughout this application, various publications, including UnitedStates patents, are referenced by author and year and patents by number.Full citations for the publications are listed below. The disclosures ofthese publications and patents in their entireties are herebyincorporated by reference into this application in order to more fullydescribe the state of the art to which this invention pertains.

The invention has been described in an illustrative manner, and it is tobe understood that the terminology, which has been used is intended tobe in the nature of words of description rather than of limitation.

Obviously, many modifications and variations of the present inventionare possible in light of the above teachings. It is, therefore, to beunderstood that within the scope of the appended claims, the inventioncan be practiced otherwise than as specifically described.

What is claimed is:
 1. A motor device for stimulating muscle,comprising: at least one electrode for generating electric currentoperatively attached to an electrode array and exposed on an innersurface of an array body, and a programming mechanism of a computer thatexecutes an algorithm stored on non-transitory computer readable mediumand includes an information storage mechanism and a user-operatedinterface in electrical connection with said at least one electrode forprogramming operation of said at least one electrode, said motor devicebeing implanted in an individual and applying electric current to nervesat an area above an area of neurological damage.
 2. The motor device ofclaim 1, wherein said electrode array is in the shape of a cuff forwrapping around a nerve root.
 3. The motor device of claim 1, whereineach said at least one electrode further includes a wire lead thatpasses through said array body and exits at an outer surface and isconnected to a source of electric current.
 4. The motor device of claim3, wherein said wire lead is coated with an insulating polymer chosenfrom the group consisting of silicones, photo-patternable silicone,hydroxylated urethane, polyimides, polytetrafluoroethylene, and flexiblepolymers having a high dielectric constant.
 5. The motor device of claim3, wherein said at least one electrode is made of a material chosen fromthe group consisting of surgical stainless steel, gold wire, indium/goldalloy, photo-patterned gold, and layers of photo-patterned chromium andgold.
 6. The motor device of claim 1, wherein said array body has a longaxis of 2 to 3 cm.
 7. The motor device of claim 1, wherein said arraybody has a short axis of 2.3 to 2.8 cm.
 8. The motor device of claim 1,wherein multiple electrodes are arranged in circumferential rows alongsaid inner face.
 9. The motor device of claim 8, wherein said multipleelectrodes are arranged in lines of dots 0.1 to 2.5 mm in diameter. 10.The motor device of claim 9, wherein said lines are 1 mm to 1 cm apart.11. The motor device of claim 1, wherein said array body is made of amaterial chosen from the group consisting of silicones,photo-patternable silicone, hydroxylated urethane, polyimides,polytetrafluoroethylene, polyrurethane, and polydimethylsiloxane. 12.The motor device of claim 1, wherein said electrode array furtherincludes multiple flaps having holes for suturing within an individual'sbody.
 13. The motor device of claim 3, further including a battery inelectrical connection with said wire lead.
 14. The motor device of claim1, wherein said computer is in electronic communication with a remoteinterface chosen from the group consisting of a smart phone, a touchscreen device, a voice-activated device, and a thought-activated device.15. The motor device of claim 1, wherein said algorithm can setparameters chosen from the group consisting of timing of electricalpotential applied at different electrodes in said electrode array,varying the intensity of electrical current applied at differentelectrodes in said electrode array, use of variable frequency trains,relaxation kinetics, stimulation frequency, shortening history, constantstimulation, randomized frequency, randomized current amplitude,randomized pulse width, and combinations thereof.
 16. The motor deviceof claim 1, further in electronic communication with a sensory deviceincluding a biofeedback mechanism for sending information generated bysaid motor device to the spinal cord.
 17. The motor device of claim 16,wherein said sensory device is programmable and includes computerstorage and an algorithm stored on non-transitory computer readablemedium for controlling and sending information.
 18. The motor device ofclaim 16, further in communication with an information harvesting deviceincluding a mechanism for harvesting information directly from the brainand motor cortex and sending said information to said motor device,wherein said motor device, sensory device, and information harvestingdevice act as an artificial spinal cord.